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HER2-positive Breast CancerPhase 1NCT00436254

Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer

A Phase 1 study testing pNGVL3-hICD vaccine, sargramostim and flow cytometry in people with HER2-positive Breast Cancer and Stage III Ovarian Epithelial Cancer, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
pNGVL3-hICD vaccine, sargramostim and flow cytometry
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
Oct 2001to 1 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Breast cancer: stage III or stage IV breast cancer with metastasis in remission and defined as NED (no evidence of disease); stable or healing bone disease by radiologic evaluation which may include, but is not limited to, bone scan, MRI, or PET scan documented within 90 days of enrollment to study and NED status for extraskeletal metastasis
  • Ovarian cancer: stage III or stage IV ovarian cancer in first complete remission with a normal AND stable CA-125; thus, two sequential normal CA-125 values will need to be documented; a minimum of 30 days between 2 sequential CA-125 values; the most recent will be within 2 weeks of enrollment into study
  • HER2 overexpression by immunohistochemistry (IHC) of 2+ or 3+ in their primary tumor or metastasis, and if overexpression is 2+ by IHC or in the absence of IHC, then patients must have documentation of HER2 gene amplification by FISH
  • Eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and corticosteroids for at least 1 month prior to enrollment; patients with stage III/IV breast cancer who have completed chemotherapy and are continued on trastuzumab monotherapy are eligible; hormonal and bisphosphanate therapies are allowed
  • Subjects must have a Performance Status Score (Zubrod/ECOG Scale) = 0
  • All subjects must no longer be able to bear children
Show all 15Show fewer
  • Hematocrit >= 30
  • Platelet count >= 100,000
  • WBC >= 3,000/ul
  • Creatinine =< 2.0 or creatinine clearance >= 60 ml/minute
  • Serum bilirubin < 1.5 mg/dl
  • SGOT < 2 x ULN
  • Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment or survival
  • Normal ANA, anti-dsDNA and C3
  • Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) of MUGA scan or echocardiogram

Who cannot join

  • Subjects cannot be simultaneously enrolled on other treatment studies
  • Any contraindication to receiving GM-CSF based vaccine products
  • Prior known history of cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart or symptomatic pericardial effusion
  • Prior known history of pulmonary disease other than controlled asthma
  • Active autoimmune disease
  • Subjects cannot have active immunodeficiency disorder, e.g., HIV

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase I Study of a DNA Plasmid Based Vaccine Encoding the HER-2/Neu Intracellular Domain in Subjects With HER-2/Neu (HER2) Overexpressing Tumors

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for breast cancer and ovarian cancer. PURPOSE: This phase I trial is studying the side effects and identifying the best dose of vaccine therapy when given together with sargramostim in treating patients with stage III-IV breast cancer or ovarian cancer.

Read the detailed description

PRIMARY OBJECTIVES: I. To determine the safety of intradermal administration of 3 doses of a plasmid-based DNA vaccine encoding the ICD of HER2 administered with a fixed dose of GM-CSF. II. To determine whether a plasmid DNA vaccine encoding the ICD of HER2 can elicit HER2 specific immune responses. SECONDARY OBJECTIVES: I. To determine if the dose of the plasmid-based DNA vaccine effects immunologic responses. II. To determine the persistence of DNA at the site of vaccination. OUTLINE: This is a dose-escalation study of a plasmid-based DNA (pNGVL3-hICD) vaccine. Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 15 years with primary physicians.

Being tested
pNGVL3-hICD vaccine, sargramostim, flow cytometry, immunologic technique, immunoenzyme technique
Medical subject headings
Carcinoma, Ovarian Epithelial, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pNGVL3-hICD vaccineBiological

    Plasmid-based DNA vaccine, given intradermally

  • sargramostimBiological

    Also called GM-CSF, granulocyte macrophage colony-stimulating factor, Leukine, Prokine

    Given intradermally

  • flow cytometryOther

    Correlative studies

  • immunologic techniqueOther

    Also called immunological laboratory methods, laboratory methods, immunological

    Correlative studies

  • immunoenzyme techniqueOther

    Also called immunoenzyme techniques

    Undergo ELIspot (correlative studies)

  • protein expression analysisGenetic

    Undergo ELISA (correlative studies)

  • biopsyProcedure or surgery

    Also called biopsies

    Undergo punch biopsy (correlative studies)

Study groups in NCT00436254
Study groupRoleWhat they receive
Arm IExperimentalPatients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity.
Receives: Biological: pNGVL3-hICD vaccine; Biological: sargramostim; Other: flow cytometry; Other: immunologic technique; Other: immunoenzyme technique; Genetic: protein expression analysis; Procedure: biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as measured by NCI CTCAE v 3.0

    Measured: From baseline

  2. Immune response

    Measured: From baseline

Secondary outcomes (2)

  1. Impact of dose on immunologic response

    Measured: From baseline to month 15

  2. Persistence of DNA at the injection site

    Measured: At 1 and 6 months after last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2007 (estimated)
  2. Study startOct 2001
  3. Primary completionMar 2010
  4. Study completion1 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00436254
Sponsor's protocol ID
6532
Other IDs
NCI-2010-00869, RG1704001
Status last verified
Apr 2025
First submitted
15 Feb 2007
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Disis MLN, Guthrie KA, Liu Y, Coveler AL, Higgins DM, Childs JS, Dang Y, Salazar LG. Safety and Outcomes of a Plasmid DNA Vaccine Encoding the ERBB2 Intracellular Domain in Patients With Advanced-Stage ERBB2-Positive Breast Cancer: A Phase 1 Nonrandomized Clinical Trial. JAMA Oncol. 2023 Jan 1;9(1):71-78. doi: 10.1001/jamaoncol.2022.5143.

    PubMed 36326756

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pNGVL3-hICD vaccine, sargramostim and flow cytometry in people with HER2-positive Breast Cancer and Stage III Ovarian Epithelial Cancer, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as measured by NCI CTCAE v 3.0 (time frame: From baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00436254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

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